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Safety and Efficacy of CJ-50300 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00607243
Recruitment Status : Completed
First Posted : February 5, 2008
Results First Posted : July 9, 2013
Last Update Posted : July 9, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
The currently available stock of smallpox vaccine would be insufficient in the face of an incident of smallpox attack. Thus, new manufacturing methods for smallpox vaccine are urgently needed because previous manufacturing methods using calf lymph are no longer acceptable in the view of current standards. Recently, CJ corporation in Republic of Korea has developed cell-culture derived smallpox vaccine (CJ-50300) which was manufactured by infecting MRC-5 cells. The aim of this clinical trial were to assess safety, reactogenicity, and immunogenicity of CJ-50300.

Condition or disease Intervention/treatment Phase
Smallpox Biological: smallpox vaccine CJ-50300 Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Double Blind, a Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of CJ-50300 in Healthy Volunteers
Study Start Date : January 2008
Primary Completion Date : June 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smallpox
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Conventional dose group
Conventional CJ-50300 2.5 x 100000 pfu/dose vaccination
Biological: smallpox vaccine CJ-50300
Conventional dose group: 2.5 x 10 5 pfu/dose Diluted dose group:2.5 x 10 4 pfu/dose
Other Name: CJ-53300
Experimental: Low dose group
Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
Biological: smallpox vaccine CJ-50300
Conventional dose group: 2.5 x 10 5 pfu/dose Diluted dose group:2.5 x 10 4 pfu/dose
Other Name: CJ-53300

Outcome Measures

Primary Outcome Measures :
  1. Cutaneous Take Reaction [ Time Frame: 7-9 day ]
    The "take reaction"was defined as a vesicular or pustular lesion or an area of definite palpable induration or congestion surrounding a central lesion (a crust or ulcer) occurring at the vaccination site at any of post-vaccination days (PVDs) 6-8. The vaccination site was photographed, and measures were taken.

  2. Adverse Reactions [ Time Frame: 0-28 days ]

Secondary Outcome Measures :
  1. Antibody Response [ Time Frame: 14 or 28 days ]
  2. Cell-mediate Immunity [ Time Frame: 14 or 28 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Healthy Korean male and female subjects between 20 and 60 years of age at the time of screening visit
  2. Willing to participate and have signed the informed consent form
  3. In good general health, without clinically skin diseases history, physical examination or laboratory test results
  4. Hematocrit > 33% for women; > 38% for men
  5. White cell count 3,300-12,000/mm3
  6. Total lymphocyte count > 800 cells/mm3
  7. Subjects who have never been vaccinated with smallpox vaccines

Exclusion Criteria:

  1. Diseases or conditions that cause immunodeficiency (For examples; HIV AIDS, leukemia, lymphoma, generalized malignancy, agammaglobulinemia, history of transplantation, therapy with alkylating agents, antimetabolites, radiation, or oral or parenteral corticosteroids).
  2. In close physical contact (household or at work) with an individual who has the diseases or conditions that cause immunodeficiency
  3. History or present of eczema or atopic dermatitis
  4. Allergy or sensitivity to any known components of vaccine or other medicines
  5. In close physical contact (household or at work) with an individual who has acute or chronic skin conditions such as dermatitis, exfoliative dermatitis
  6. Subjects requiring steroid therapy
  7. Subjects who are taking immunosuppressive therapy
  8. Subjects who are planning for blood donations
  9. Autoimmune disease such as lupus erythematosus
  10. Subjects who work in medical institution
  11. Household contacts with women who are pregnant or breast-feeding
  12. Female subjects who are pregnant or breast-feeding and have positive result by serum pregnancy test or urine pregnancy test, or do not using approved contraceptives such as sterilization, contraceptive ring injectable, combined oral contraceptive pills and barrier contraceptive, combined hormone-based therapy, contraceptive cream, contraceptive jelly, diaphragm or condoms
  13. Subjects household member < 1 year old or work with children < 1 year old
  14. Subjects with a known history of Cardiac disease or have three or more of the following risk factors: hyperpiesia, obesity, hyperlipidemia, glucosuria, sclerosis, cerebral arteriosclerosis
  15. Receipt of immunoglobulin and steroid within 14 days of vaccination
  16. Receipt of investigational research agents within 120 days of vaccination
  17. HBsAg seropositive
  18. HCV antibody seropositive
  19. HIV seropositive
  20. Subjects having fever (oral temperature > 38℃) or severe nutrition disorder
  21. Blood donation within 12 weeks in advance screening visit
  22. Subject who are not suitable to participate in study according to investigator's judgement
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607243

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
CJ HealthCare Corporation
Principal Investigator: Myoung-don Oh, M.D. Seoul National University Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Myoung-don Oh, Professor, Division of Infectious Diseases, Department of Internal Medicine, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00607243     History of Changes
Other Study ID Numbers: CJ_SPX_301
CJ corporation ( Other Identifier: CJ corporation )
First Posted: February 5, 2008    Key Record Dates
Results First Posted: July 9, 2013
Last Update Posted: July 9, 2013
Last Verified: July 2013

Keywords provided by Myoung-don Oh, Seoul National University Hospital:
Smallpox vaccine efficacy

Additional relevant MeSH terms:
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Immunologic Factors
Physiological Effects of Drugs